A Study of RO4917523 in Patients With Fragile X Syndrome

Roche

Status and phase

Completed

Phase 2

Conditions

Fragile X Syndrome

Treatments

Drug: RO4917523 0.5 mg

Drug: Placebo

Drug: RO4917523 1.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01517698

NP27936

Details and patient eligibility

About

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

Enrollment

185 patients

Sex

All

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult and adolescent patients, 14-50 years of age
Diagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1) full mutation and qualifying scores on the Aberrant Behavior Checklist (ABC) and CGI-S
Patients must agree to either remain completely abstinent or to use two effective contraceptive methods during and 3 weeks after the study

Exclusion criteria

Previous treatment with another metabotropic glutamate (mGLU) receptor antagonist within 18 months or with RO4917523
Participation in a clinical trial involving an investigational (unapproved) drug within 3 months or 5 times the half-life (whichever is longer) before start of this study
Any uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome
History of suicidal behavior